Seeking Feedback: The FDA and Product Tracing

The Food Safety Modernization Act continues to spur discussion and debate among various interests. Recently, results on several trials concerning product tracing in the food supply were released by the FDA. The FDA utilized numerous different stakeholders, including several private sector firms that volunteered for the process. This initial round of tracing activities was focused on foods associated with foodborne illness, including tomatoes as well as: “chicken/peanuts/spices in processed foods.”

The findings potentially have the ability to change the way that the FDA conducts investigations, and it could: “affect how industry interacts with the Agency to provide product tracing information.” Public comment is welcome at this point on the findings. At this juncture the following recommendations have been made as presented below, in the “Executive Summary” (and can be accessed, along with the entire final report here):

  1. “ From an overarching perspective, IFT recommends that FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping requirements based on risk classification.
  2. FDA should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of CTEs and KDEs as determined by FDA.
  3. Each member of the food supply chain should be required to develop, document, and exercise a product tracing plan.
  4. FDA should encourage current industry-led initiatives and issue an Advance Notice of Proposed  Rulemaking or use other similar mechanisms to seek stakeholder input.
  5. FDA should clearly and more consistently articulate and communicate to industry the information it needs to conduct product tracing investigations.
  6. FDA should develop standardized electronic mechanisms for the reporting and acquiring of CTEs and KDEs during product tracing investigations.
  7. FDA should accept summarized CTE and KDE data that are submitted through standardized reporting mechanisms and initiate investigations based on such data.
  8. If available, FDA should request more than one level of tracing data.
  9. FDA should consider adopting a technology platform that would allow efficient aggregation and analysis of data submitted in response to a request from regulatory officials. The technology platform should be accessible to other regulatory entities.
  10. FDA should coordinate traceback investigations and develop response protocols between state and local health and regulatory agencies, using existing commissioning and credentialing processes. In addition, FDA should formalize the use of industry subject matter experts in product tracing investigations.”

To find out how to comment on the report or on the above recommendations visit this site.

A Picture of Mathew J. Bartkowiak, Ph.D.

About Mathew J. Bartkowiak, Ph.D.

Laboratory Products Department Manager, Nelson-Jameson, Inc.
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